I. Field of the Invention
The invention relates to the fields of molecular and cellular biology, particularly to the use of antibodies to detect antigens diagnostic of genitourinay cancer in urine, semen or prostatic fluid.
II. Related Art
Bladder cancer is the fifth most common cancer in the United States accounting for about 4.6% of all cases (Jemal et al., 2007). Most incidences of bladder cancer are superficial and localized in character with about 74% of all cases being localized when diagnosed (Jemal et al., 2007). It exists in two main forms, non-invasive which lacks invasion into surrounding muscle tissue and is the more common form accounting for 75% of all cases and muscle invasive in which it spreads into surrounding urinary areas and may metastasize (Sengupta and Blute, 2006).
When diagnosed at early stages bladder cancer has about a 94% survival rate, but this rate drops dramatically to 46% when the cancer has spread to the surrounding region and to 6% when the cancer is distant at diagnosis (Jemal et al., 2007). Although most forms are non-invasive they have a large risk of recurrence after treatment (>50%) and high-grade superficial lesions carry a significant risk of progression (Sengupta and Blute, 2006).
The standard method of diagnosing bladder cancer is visualization by cystoscopy (Clark, 2007). However this technique is invasive, costly, and is limited by needing sight interpretations of growths (Sengupta and Blute, 2006). Inspection of cells in urine for abnormalities (urine cytology) and detection of chromosomal abnormalities in those cells (FISH or fluorescence in situ hybridization) are two other common methods of diagnosis without the invasiveness of cytology (Sengupta and Blute, 2006; Clark, 2007). However, urine cytology has very low sensitivity in detection of low grade disease (Sengupta and Blute, 2006; Clark, 2007) and FISH, while better at detecting low grade forms still carries low specificity and sensitivity and is subject to wide variation in effectiveness among cases (Clark, 2007).
More sensitive and specific early detection tools for bladder cancer and other genitourinary cancers would greatly improve patient survival. Also given the high recurrence rate, an easy follow up procedure that could be administered regularly would greatly improve treatment of recurrences. Urine, semen and prostatic fluid analysis, these fluids having come into close contact with genitourinary tissues, provides a tool unique to these kinds of cancer. Advantageously, such procedures are non-invasive and easy to administer. However, such techniques also require a marker of the disease that can be detected with high specificity and sensitivity in patients, which heretofore has not yet been identified.